Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml

On April 6, 2023, the U.S. Food and Drug Administration (FDA) issued a final decision ordering the withdrawal of the approval of Makena® (hydroxyprogesterone caproate injection, 250 milligrams (mg) per mL) and its generics. FDA recognizes that there is a supply of product that has already been distributed. Patients who have questions should talk to their healthcare provider. We recommend health care practitioners consider FDA’s conclusions.

If you have questions or concerns about receiving your therapy as prescribed, consult your healthcare provider.

https://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena